Biosimilar pipeline

Polpharma Biologics has its own pipeline of biosimilars for out- licensing. We are focused on advancing and expanding our product portfolio to increase patient access to these much-needed therapies and are open to partnering with other organizations to co-develop or commercialize our biosimilars.

Biologics in the pipeline

Development & manufacturing facilities

> 10000 l

Bioreactor production capacity

Over 800

People employed

Over 50

Polish scientists returned from abroad

We care

our driving value for what we do

Polpharma Biologics has developed and partnered an expanding pipeline of biosimilars to treat a number of conditions across major therapeutic areas. Our proprietary cell line development platform, highly efficient process development as well as extensive manufacturing capabilities have allowed us to rapidly expand our pipeline.

We are highly focused on advancing and expanding our product portfolio and are continually evaluating potential biosimilars. To increase the patient access to these much-needed therapies we actively seek to partner with other organisations to co-develop or commercialize our biosimilars.

Read about our partnership opportunities

Our Biosimilar Pipeline

Ranibizumab FYB201

Lucentis®

Ophthalmology

Through BIOEQ: Teva/Coherus

EMA*, FDA*, MHRA*

Natalizumab PB006

Tysabri®

Multiple Sclerosis

Sandoz

FDA, EMA

Vedolizumab PB016

Entyvio®

Immunology

Ocrelizumab PB018

Ocrevus®

Multiple Sclerosis

Undisclosed PB019

Immunology

Undisclosed PB020

Blood Disorders

Undisclosed PB021

Various

INN Ranibizumab FYB201

Reference medicine Lucentis®

Therapeutic Area Ophthalmology

Partner Through BIOEQ: Teva/Coherus

Cell line development

Process and formulation development

Clinical development

Submission preparation

In review

Approved EMA*, FDA*, MHRA*

INN Natalizumab PB006

Reference medicine Tysabri®

Therapeutic Area Multiple Sclerosis

Partner Sandoz

Cell line development

Process and formulation development

Clinical development

Submission preparation

In review

Approved FDA, EMA

INN Vedolizumab PB016

Reference medicine Entyvio®

Therapeutic Area Immunology

Partner -

Cell line development

Process and formulation development

Clinical development

Submission preparation

In review

Approved

INN Ocrelizumab PB018

Reference medicine Ocrevus®

Therapeutic Area Multiple Sclerosis

Partner -

Cell line development

Process and formulation development

Clinical development

Submission preparation

In review

Approved

INN Undisclosed PB019

Reference medicine -

Therapeutic Area Immunology

Partner -

Cell line development

Process and formulation development

Clinical development

Submission preparation

In review

Approved

INN Undisclosed PB020

Reference medicine -

Therapeutic Area Blood Disorders

Partner -

Cell line development

Process and formulation development

Clinical development

Submission preparation

In review

Approved

INN Undisclosed PB021

Reference medicine -

Therapeutic Area Various

Partner -

Cell line development

Process and formulation development

Clinical development

Submission preparation

In review

Approved

*Launched

Project:

Ranibizumab FYB201

Partner:

Bioeq AG

Originator:

Lucentis®

Originator annual sales:

$4bn (2019)

Therapeutic Area:

Ophthalmology

Ranibizumab (trade name Lucentis® among others) is a monoclonal anti-angiogenic antibody fragment (Fab) that has been approved to treat the "wet" type of age-related macular degeneration a common form of age-related vision loss. In 2019, Lucentis® generated global sales of more than USD 3.9 billion, with revenue growth continuing at a significant rate. Ranibizumab inhibits angiogenesis by inhibiting vascular endothelial growth factor A.

Ranibizumab biosimilar FYB201

Polpharma Biologics’ joint venture company, Bioeq, in collaboration with Formycon, is working on a Ranibizumab biosimilar, code named FYB201. FYB201 will be commercialized in the US by Coherus and by Teva Pharmaceutical Industries in Europe, Canada, Israel and New Zealand. Bioeq submitted a biologics license application (BLA) for Ranibizumab to the U.S. Food and Drug Administration in August 2021.

Project:

Natalizumab PB006

Partner:

Sandoz

Originator:

Tysabri®

Originator annual sales:

$1.9bn (2019)

Therapeutic Area:

Multiple Sclerosis

Natalizumab, sold under the brand name Tysabri® among others, is a medication used to treat multiple sclerosis and Crohn's disease. It is a monoclonal antibody which targets a protein called α4β1 integrin on white blood cells involved in inflammation. By attaching to integrin, natalizumab is thought to stop white blood cells from entering the brain and spinal cord tissue, thereby reducing inflammation and the resulting nerve damage. It was approved by the FDA in 2004 before briefly being removed from the market, it was reintroduced in 2006 when it was also approved for use in the EU.

Natalizumab biosimilar PB006

Polpharma Biologics is developing a Natalizumab biosimilar code named PB006. Our partner, Sandoz will commercialize this medicine. Global phase III & phase I PK/PD clinical trials of PB006 both completed recruitment in 2020.

Project:

Vedolizumab PB016

Partner:

Originator:

Entyvio®

Originator annual sales:

$3.2bn (2019)

Therapeutic Area:

Immunology

Vedolizumab, sold under the brand name Entyvio® is a monoclonal antibody developed by Millennium Pharmaceuticals, Inc (a subsidiary of Takeda Pharmaceuticals) for the treatment of ulcerative colitis and Crohn's disease. It binds to integrin α4β7. Blocking the α4β7 integrin results in gut-selective anti-inflammatory activity.

Vedolizumab biosimilar PB016

Polpharma Biologics is developing a Vedolizumab biosimilar PB016. Following technical proof of similarity and scale up, GMP production started in 2021. We are actively seeking partners interested in marketing or licensing this biosimilar.

Project:

Ocrelizumab PB018

Partner:

Originator:

Ocrevus®

Originator annual sales:

Therapeutic Area:

Multiple sclerosis

Ocrelizumab, sold under the brand name Ocrevus®, is used in the treatment of multiple sclerosis (MS). It was approved for use by the FDA in 2017 for primary progressive forms of MS (PPMS) and for use in the European Union in 2018. It is a monoclonal antibody that targets CD20. CD20 is found on B lymphocytes, and as such Ocrelizumab is an immunosuppressive. This helps prevent B cell induced damage to myelin surrounding nerves prevalent in MS patients.

Ocrelizumab biosimilar PB018

Polpharma Biologics is developing a Ocrelizumab biosimilar under code name PB018. We are currently in the process of transferring the cell line and clone to our Gdansk facility to take it to the next stage of technical proof of similarity. We are seeking partners interested in marketing or licensing this biosimilar.

Project:

Ipilimumab PB008

Partner:

Originator:

Yervoy®

Originator annual sales:

Therapeutic Area:

Oncology

Ipilimumab, sold under the brand name Yervoy®, is used to treat a range of cancers. It was approved for use by the FDA in 2011 for the treatment of late-stage melanoma, and in 2020 for the treatment of malignant pleural mesothelioma in combination with nivolumab. Ipilimumab is a monoclonal antibody that targets the CTLA-4 protein receptor. CTLA-4 downregulates the immune system when Cytotoxic T lymphocytes attack cancer cells preventing their destruction. Therefore CTLA-4 inhibition allows a more effective immune response.

Ipilimumab biosimilar PB008

Polpharma Biologics is developing a Ipilimumab biosimilar under code name PB008, the cell line and upstream process development is complete. We are actively seeking partners interested in further developing, marketing or licensing this biosimilar.

Project:

Pembrolizumab PB014

Partner:

Originator:

Keytruda®

Originator annual sales:

Therapeutic Area:

Oncology

Pembrolizumab, sold under the brand name Keytruda®, is a drug used in the treatment of a range of cancers. It targets the PD-1 receptor on lymphocytes allowing targeting by the immune system. Pembrolizumab has been approved in a range of countries to treat inoperable or metastatic melanoma, metastatic non-small cell lung cancer, metastatic bladder cancer, head and neck squamous cell carcinoma, classic Hodgkin's lymphoma and metastatic esophageal squamous cell carcinoma.

Pembrolizumab biosimilar PB014

Polpharma Biologics is developing a Pembrolizumab biosimilar under code name PB014, we have finished the development of a cell line and have developed upstream and downstream processes, we are actively seeking partners interested in further developing, marketing or licensing Pembrolizumab.

Project:

Nivolumab PB015

Partner:

Originator:

Originator annual sales:

Therapeutic Area:

Oncology

Nivolumab, sold under the brand name Opdivo®, it is a immunotherapeutic drug used for the treatment of a variety of cancers. It is currently approved for the treatment of melanoma, non-small cell lung cancer, kidney cancer and classical Hodgkin lymphoma. Similar to Pembrolizumab It is an immune-checkpoint inhibitor that blocks PD-1, to allow the activation of T-cells which attack the cancer.

Nivolumab biosimilar PB015

Polpharma Biologics is developing a Nivolumab biosimilar under code name PB015, we have finished the development of a cell line and have developed upstream and downstream processes, we are actively seeking partners interested in further developing marketing or licensing Nivolumab.